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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POLIDENT DENTURE ADHESIVE CREAM

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POLIDENT DENTURE ADHESIVE CREAM Back to Search Results
Lot Number P42W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Argus case: (b)(4).
 
Event Description
It seemed that i had eaten a lot of it [accidental device ingestion].I have been sick for 10 days after using it.I almost didn't want to move [sickness].I have nausea [nausea].I have headache [headache].I have tight ears [ear disorder].But i kept getting sick and it seemed that i was very uncomfortable [discomfort].I just felt nauseous and vomited [vomiting].Had tinnitus [tinnitus].My speech is normal now [speech disorder].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a elderly female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number: p42w, expiry date october 2025) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced accidental device ingestion (serious criteria haleon medically significant and other: haleon medically significant), sickness, nausea, headache, ear disorder, discomfort, vomiting, tinnitus, speech disorder and product complaint.The action taken with polident denture adhesive cream was unknown.On an unknown date, the outcome of the accidental device ingestion, sickness, nausea, headache, ear disorder, discomfort, vomiting and tinnitus were recovering/resolving and the outcome of the speech disorder was recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the accidental device ingestion, sickness, nausea, headache, ear disorder, discomfort, vomiting, tinnitus and speech disorder to be related to polident denture adhesive cream.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from consumer via call center representative(phone) on (b)(6) 2024.The consumer reported that "i want to ask you, i bought polident denture adhesive cream (non-sterile) good stability max comfort 70g.I bought it at.I bought it before.I don't know if i got a newer one or something.The one i bought before came out pink, but the one i bought now comes out white and thinner.From your description, this one is relatively new.I have been sick for 10 days after using it.I have nausea, headache, and tight ears.I originally don't know the reason for this.I thought that i didn't do anything.Why is it so severe? after i stopped it for 2 days, my speech is normal now.Moreover, its viscosity is very bad and it is easy to eat.I bought the new one at.I bought polident denture adhesive cream (nonsterile) good stability max comfort 70g.When i went to buy it, i thought the most expensive one was the best.The one i bought this time squeezed out a little thinner, but i felt that its viscosity was very bad.It seemed that i had eaten a lot of it.I wanted to try it a few more times.But i kept getting sick and it seemed that i was very uncomfortable.I didn't know the reason for this.I could still think, i was wondering why i was so severe, so i stopped.I stopped almost two or three days ago.I am in my 70s.I walked far away and came back.I seemed to have regained my strength.I ate so much, what impact will it have? why didn't i take out so much when cleaning? we all had to pick it off.I used my fingers to do it, but i didn't do it so many times.I used the mint one before, which was thicker, so i could get it all.I was very strange.Finally, i decided to stop it and take a look.I can't just use it once and then tell you that there's something wrong with your product.Sometimes i'm sick and i can't talk nonsense, so i tried i've been taking it for several days, and it seems to have stopped for 2 or 3 days today.I feel more comfortable today.I have been using your polident denture cleanser for a long time.The adhesive is only in the past few years.I think i have been using it for two or three years.After a while, i thought about what to do next.The previous one was thicker and pink when extruded, but now this new one is thin and white when extruded.The last one will break after using it, and the outer packaging next to it will seep out, so i will wrap the new one with tape because i am afraid it will break again.The tube is broken near the upper part.This has not happened with the new one, but i wrapped it with tape first.I squeezed the new one a little longer, and when i brushed my teeth at night, it almost fell off halfway.This new one is very uncomfortable to use.I would be a little scared if i swallowed it.Will it have any effects? i started having problems as soon as i got the new one.I didn't know that i was sick for many days.I almost didn't want to move.I just felt nauseous and vomited, had a headache, and my ears were so tight.I didn't believe it was this.I didn't know it at the time.I thought of this because i was so sick that i felt a little weird.What was wrong with me? which doctor should i see? my child kept asking me to take me to see a doctor.Who should i see? i didn't know.So i thought about it.I stopped using it myself to take a look, and it turned out that i felt better the next day.I took it off during the day when i was eating, and it seems to have been there for three or four days now.When i walked out this morning, i seemed to be fine.Well, let me tell you this.I recovered a little bit, but in those days i vomited, had headaches, tinnitus, and my ears were very tight.They told me to open my mouth.I pouted, and it felt comfortable.After a while, it came again, very uncomfortable.I don't remember exactly when this happened.It seems that i felt uncomfortable the same day or the next day after using it.I don't know if it lasted a week or 10 days.Batch number: p42w, expiry date: 2025/10, i haven't seen a doctor either.Whether the body has recovered was reported as in recovery.Have you ever seen a doctor was reported as no.Follow up information was received from quality assurance department on 20mar2024 regarding case number: (b)(4) regarding lot number: p42w.Investigation evaluation: this is the third complaint of this nature for this batch.A notification review check was carried out on this batch which relates to manufacturing deviations, vendor investigations, change controls and laboratory investigations.There were no issues noted during the manufacture of this batch as per the defect of this complaint received, therefore, no further actions will be taken at this time.This case is deemed unsubstantiated.Due to the related hsi with an ae, could i kindly request that further information is requested from the complainant.Should the complaint sample become available the case will be reopened.The complaint was concluded as unsubstantiated.The product complaint number was reported as (b)(4).The initial and follow up reports were processed together.
 
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Brand Name
POLIDENT DENTURE ADHESIVE CREAM
Type of Device
DENTURE ADHESIVE
Manufacturer Contact
184 liberty corner road
suite 200
warren, NJ 07059
MDR Report Key18977007
MDR Text Key338559551
Report Number3003721894-2024-00042
Device Sequence Number1
Product Code KOT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberP42W
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/18/2024
Initial Date FDA Received03/26/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NO THERAPY (NO THERAPY).
Patient Outcome(s) Other;
Patient SexFemale
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